Shoulder Innovations Receives 510(k) FDA Clearance for Titanium Implant

04:34 PM EDT, 09/10/2026 (MT Newswires) -- Shoulder Innovations (SI) has received the US Food and Drug Administration's 510(k) clearance for the N-22 Humeral Head titanium implant for patients with metal hypersensitivity, the company said late Thursday. The company said it also initiated the product's full commercial launch. The implant is designed for anatomic total shoulder arthroplasty procedures and complements the company's N-22 Glenosphere implant used in reverse total shoulder arthroplasty procedures, the company said.